Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Adminstration of Oral form of herbal component ''Neurotec'' as capsules containing 120mg of active ingredient(which belong to Flavonoids:Isoquercetin,4-Methoxyisoquercetin and Rutin) in patients with diagnosis of fibromyalgia according to American College of Rheumatology (ACR) criteria. Patients will take the drug as oral, twice a day for 8 weeks.

Query!

Intervention code [1]36040

Treatment: Drugs

Query!

Comparator / control treatment

Adminstration of Oral form ''Placebo''. Placebo has been made as capsules exactly similar to drug containing starch. Patients will take Placebo as oral, twice a day for 8 weeks.

Query!

Control group

Placebo

Query!

Outcomes

Primary outcome [1]49740

Number of tender points (out of 18 possible tender points). This can be achieved through physical examination by the trained reumatologist.

Query!

Timepoint [1]49740

Patients will be visited every other week by a Rheumatologist during the first 8 weeks and every 4 weeks during thereafter untill 16th week from the start of treatment

Query!

Primary outcome [2]49750

Pain severity (sum of numerical scale of tender points).The patients will express the severity of the pain they feel in tender points according the numrical scale from min=0 to highest=10 The severity of pain for each tender point will be measured through a numerical Scale.

Query!

Timepoint [2]49750

Patients will be visited every other week by a Rheumatologist during the first 8 weeks and every 4 weeks during thereafter untill 16th week from the start of treatment

Query!

Secondary outcome [1]83890

Quality of lifeThis will be measured through applying SF-12 questionnaire which is a 12-item questionnaire for measuring both physical and mental aspect of quality of life.

Query!

Timepoint [1]83890

At baseline, 8th and 16th week of study

Query!

Secondary outcome [2]83900

Quality of life assessed by Fibromyalgia Impact Questionnaire (FIQ)

Query!

Timepoint [2]83900

Patients will be visited every other week by a Rheumatologist during the first 8 weeks

Diagnosis of Fibromyalgia defined by American college of Rheumatology criteria (Tenderness on at least 11 out of 18 points) Age more than 18 year

Query!

Minimum age

18Years

Query!

Query!

Maximum age

75Years

Query!

Query!

Gender

Both males and females

Query!

Can healthy volunteers participate?

No

Query!

Key exclusion criteria

Presence of any other rheumatologic diseasesReceiving any investigational drug within 30 days prior to screeningPresence of any other systemic or chronic diseases such as: Myopathy, Vasculitis, Peripheral Vascular Diseases, Chronic hepatic or renal diseases, clinically complicating pulmonary, Cardiac, Hematologic, Gastrointestinal, Endocrine disease or Malignancy. Pregnancy or intention of becoming pregnant during the study period (1 year) Inability to give informed consent according to the agreed process Corticosteroid therapyAny drug hypersensitivityRadiotherapy, Chemotherapy or any immuosuppressive drug useElectrolyte imbalance

Query!

Study design

Purpose of the study

Treatment

Query!

Allocation to intervention

Randomised controlled trial

Query!

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Randomisation will not be exposed to those conducting the study and will be provided in closed letters with successive numbers. The envelope will be opened when a patient is going to join the study.The study will be double blind. The patient, those who conduct the study and those who analyse the results will be unaware of the state of the patient with regard to receiving the active drug or placebo. For this to happen patients will be blinded by using a placebo which is identical to active drug in appearance but the content is a biologically inert substance. To blind those who conduct the study, the person who delivers the study drug will be different from those who examine the patients. Finally the randomisation table will be concealed from research staff by using closed envelops.

Query!

Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

There are 11 centres. Patients in each centre will be allocated to the intervention or control groups using a separate complete block randomisation method. Randomisation will not be exposed to those conducting the study and will be provided in closed letters with successive numbers. The envelope will be opened when a patient is going to join the study.

Query!

Masking / blinding

Blinded (masking used)

Query!

Who is / are masked / blinded?

Query!

Query!

Query!

Query!

Intervention assignment

Parallel

Query!

Other design features

Query!

Phase

Phase 3

Query!

Type of endpoint(s)

Efficacy

Query!

Statistical methods / analysis

Query!

Recruitment

Recruitment status

Not yet recruiting

Query!

Date of first participant enrolment

Anticipated

24/11/2008

Query!

Actual

Query!

Date of last participant enrolment

Anticipated

Query!

Actual

Query!

Date of last data collection

Anticipated

Query!

Actual

Query!

Sample size

Target

2008

Query!

Accrual to date

Query!

Final

Query!

Recruitment outside Australia

Country [1]13070

Iran, Islamic Republic Of

Query!

State/province [1]13070

Tehran

Query!

Funding & Sponsors

Funding source category [1]40660

Commercial sector/Industry

Query!

Name [1]40660

Pars Roos

Query!

Address [1]40660

No:568, 13th Alley, Hormozan St., Shahrak-e-Gharb, tehran,1466793143

Query!

Country [1]40660

Iran, Islamic Republic Of

Query!

Primary sponsor type

Other Collaborative groups

Query!

Name

Iran Rheumatology Center

Query!

Address

No9, Khosravi Alley, North Kargar St., Tehran, 1413633131

Query!

Country

Iran, Islamic Republic Of

Query!

Secondary sponsor category [1]37380

None

Query!

Name [1]37380

Query!

Address [1]37380

Query!

Country [1]37380

Query!

Ethics approval

Ethics application status

Approved

Query!

Ethics committee name [1]61490

Endocrine & Metabolism Research Center Ethic Committee

Query!

Ethics committee address [1]61490

Fifth Floor, Shariaty Hospital, North Kargar St., Tehran, 14114

Query!

Ethics committee country [1]61490

Iran, Islamic Republic Of

Query!

Date submitted for ethics approval [1]61490

23/09/2008

Query!

Approval date [1]61490

27/10/2008

Query!

Ethics approval number [1]61490

E-0009

Query!

Summary

Brief summary

This is a Phase III multicenter clinical trial of the herbal oral component of Neurotec in patients with Fibromyalgia.The intervention period is 8 weeks and patients will be followed for another 8 weeks after the end of intervention. This study will be conducted with control group with Placebo.